Reliance Lumbar IBF System— 510(k) K173283

Clearance details

Applicant

Reliance Medical Systems, LLC

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2017-10-16

Decision date

2018-01-19

Decision

Substantially Equivalent

Clearance type

Special

Location

Bountiful, UT, US

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• K202266 — Reliance Cervical IBF System2022-03-29
• K210874 — Reliance Spinal Screw System2021-05-13
• K183049 — Reliance Lumbar IBF System2019-02-15
• K173102 — Reliance Cervical IBF System2017-12-29
• K172489 — Reliance Cervical IBF System2017-09-07

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →